MAUDE Adverse Event Report: ILLUMINOSS MEDICAL, INC PHOTODYNAMIC BONE STABILIZATION SYSTEM; IN VIVO INTRAMEDUILLARY FIXATION ROD

Catalog Number CT-0226

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2020

Event Type  malfunction  

Event Description

This mdr report is based on the reclassification of a previously reviewed complaint.It was reported by a user in potsdam, germany that during preparation for implanting an illuminoss implant to treat a humeral fracture, an illuminoss 6.5mm reamer broke.

Manufacturer Narrative

This mdr report is based on the reclassification of a previously reviewed complaint.Followup information provided by user: the 2.0mm guidewire was in the patient's intramedullary canal, and the cannulated 6.5mm reamer was inserted over the guide wire.The user removed the reamer back and forth and suddenly saw under fluoroscopy, that the reamer appeared to be stretching and finally broke in three places at the proximal end of the reamer.Because of the ball tip guidewire that has been used, all parts of the reamer could be completely removed out of the patient intramedullary canal.After that, the user used the larger sizes of the reamer and had no further problems.The reamer could easily be pushed back and forth.The surgery was successfully completed.Records review: a review of manufacturing records was performed, and found that the device met speciations at the time of manufacture and release.Returned product evaluation: the device was received on (b)(6) 2021.Analysis of the break observed that it was a clean break, which is consistent with the device breaking at high speed.There was no evidence of any deformation of the material (steel) which would have been expected if the material stretched as reported by the user.The break pattern observed in the returned device is consistent with over-torquing of the device during use.The description of the sequence of events provided by the user indicates that the distal portion of the device (the tip) may have become lodged in the canal and unable to release itself before the torque created by the powered handle placed enough force on the reamer to break it.Conclusion: existing evidence supports that over-torquing of the device is the probable cause of this event, although this cannot be definitely proven with the evidence available to the firm at this time.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN VIVO INTRAMEDUILLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL, INC; 993 waterman ave; east providence RI 02914
• Manufacturer (Section G): ILLUMINOSS MEDICAL, INC; 993 waterman ave; east providence RI 02914
• Manufacturer Contact: robert rabiner ; 993 waterman ave; east providence, RI 02914 ; 4017140008
• MDR Report Key: 16824862
• MDR Text Key: 314109376
• Report Number: 3006845464-2023-00022
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K181228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CT-0226
• Device Lot Number: 351307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male